FDA device listing

LIMB#PHYSICAL MEDICINE,REPLACEMENT WRAPS

FDA device listing 1902307308 · DJO, LLC

Key facts

Proprietary names LIMB#PHYSICAL MEDICINE,REPLACEMENT WRAPS
Owner/operator DJO, LLC
Owner/operator number 9015378
Product codes IPM
Device names IPM - Cover, Limb
Device class Class I
Classification regulations (21 CFR) 890.3025
Review panels Physical Medicine
Registered establishments DJO, LLC, DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V., DJO Tunisia, DJO Tunisie
Establishment registrations 9616086, 3007615436, 3011120089, 3017264244
FEI numbers 3006076154, 3007615436, 3011120089, 3017264244
Establishment operations Manufacturer, Repackager/Relabeler, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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